MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-01 for HUDSON MASK,MULTI-VENT,ADULT 1088 manufactured by Teleflex Medical.
[140431828]
(b)(4). The device involved has not been received by the manufacturer for evaluation at the time of this report. The device history record (dhr) of batch number 74c1600188 that belongs to catalog number 1088 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. Dhr shows that the product was assembled and inspected according to our specifications. To perform a proper and thorough investigation, it is necessary to evaluate the sample involved in this complaint. Customer complaint cannot be confirmed based only on the information provided. Root cause cannot be determined. Corrective actions cannot be established. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[140431829]
Customer complaint alleges "she is not getting enough oxygen. The mask blows more air into eyes than nose and the metal piece over bridge of nose is off to the side". No patient harm was reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00091 |
| MDR Report Key | 8468865 |
| Report Source | CONSUMER |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-27 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2019-04-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON MASK,MULTI-VENT,ADULT |
| Generic Name | MASK, OXYGEN, LOW CONCENTRATIO |
| Product Code | BYF |
| Date Received | 2019-04-01 |
| Catalog Number | 1088 |
| Lot Number | 74C1600188 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-01 |